Sex, Psychopharmacology, and Diabetes

Not Applicable

Recruiting

• Conditions: Diabetes Mellitus; Sexual Dysfunction; Schizophrenia Spectrum and Other Psychotic Disorders; Drug-Related Side Effects and Adverse Reactions; Schizophrenia; PreDiabetes; Education
• Interventions: Behavioral: Educational intervention

• Registration Number: NCT05951660
• Lead Sponsor: Zealand University Hospital

Brief Summary

The term sexual (SD) dysfunction covers conditions that prevent people from having a satisfactory sex life. SD is a frequent and sometimes debilitating complication of mental illness and a known adverse reaction to psycho-pharmacological treatment. SD is also associated with diabetes, a common somatic comorbidity in psychiatric patients. SD is associated with both reduced quality-of-life and reduced treatment adherence, yet SD is far too rarely addressed between the patient and the healthcare professional in clinical consultations.

The purpose of the study is to investigate whether targeted education of patients with schizophrenia and diabetes/prediabetes and/or their healthcare professionals in causes and management of SD:

* Increases the number of systematic examinations of sexual side effects,

* Causes changes in the psycho-pharmacological treatment, and

* Reduces the severity or perception of sexual side effects.

The study is a multicenter Randomized Controlled Trial (RCT) with four arms, in which the educational intervention is provided to patients, healthcare professionals, or both groups. The effect of the educational intervention is compared to a non-educated control group. The study is expected to include 192 patients recruited from 16 assertive community treatment centers evenly distributed in four Danish regions.

The study is part of an interdisciplinary project named SECRET. The educational intervention was developed in an ethnographic pre-study incorporating stakeholder engagement. Parallel to the present RCT, an ethnographic field study will be carried out to broaden the perspective on the effects of the intervention.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-10
• Study First Submitted QC: 2023-07-10
• Study First Posted: 2023-07-19
• Study Start: 2023-08-24
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-07
• Last Update Posted: 2025-02-11
• Primary Completion: 2025-07-31
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 256

Inclusion Criteria

• Age ≥ 18 years

• A diagnosis in the schizophrenic spectrum (ICD10 F2x)

• One of the following:

  1. A diagnosis of diabetes (ICD10 E10x, E11x, E12x, E13x, 14x)
  2. A current or previous prediabetes defined as an HbA1c between 39-47 mmol/mol (both included) measured in at least two blood samples collected with ≥3 months intervals as part of the patient's routine clinical monitoring
  3. Obesity defined as a Body-Mass Index (BMI) ≥30 kg/m2

• Ongoing treatment with at least one antipsychotic agent

• A SD that can be rated using Changes in Sexual Function Questionnaire-14 (CSFQ-14)

Exclusion Criteria

• Incapacitated or subject to mental health probation
• Unable to speak danish

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
INT3: Both patients and Healthcare Professionals are educated	Educational intervention	-
INT1: Only patients are educated	Educational intervention	-
INT2: Only Healthcare Professionals are educated	Educational intervention	-

Primary Outcome Measures

Name	Time	Method
Changes from baseline to follow up in the total score of Changes in Sexual Function Questionnaire-14 (CSFQ-14)	At inclusion and at follow-up, i.e. 6 months after the educational intervention is finished.	Measured by Changes in Sexual Function Questionnaire-14 (CSFQ-14)

Secondary Outcome Measures

Name	Time	Method
Changes in psycho-pharmacological treatment	Recorded continuously throughout the entire study period, i.e. from the day of the educational intervention to 6 months after the end of the educational intervention.	Estimated by changes in prescribed medications
Changes from baseline to follow up in compliance / Adherence to the Pharmacological Treatment	At inclusion and at follow-up, i.e. 6 months after the educational intervention is finished.	Measured by Rating of Medication Influences (ROMI) Scale
Changes from baseline to follow up in shared decision making	At inclusion and at follow-up, i.e. 6 months after the educational intervention is finished.	Measured by Shared Decision Making-9 (SDM) measurement tool
The frequency in which sexual issues are discussed in the clinical consultation	Recorded continuously throughout the entire study period, i.e. from the day of the educational intervention to 6 months after the end of the educational intervention.	The number of systematic examinations of sexual side effects estimated by the number of consultations where sexual side effects are addressed, and whether it is the patient or the healthcare professional, who addresses the subject.

Trial Locations

Locations (1)

Assertive Community Centres; 🇩🇰 Slagelse, Denmark